Stroke, AcuteNCT03235271
Pilot Study of Acute Stroke Using the Brainpulse™
An observational study of Stroke, Acute, run by Jan Medical, Inc. at 3 sites in United States.
Trial summary
The aim of this pilot study is to collect data on stroke patients and non-stroke patients or healthy volunteers using the BrainPulse Stroke Monitor. Subject characteristics, diagnostic procedures and clinical outcomes will be documented as part of the data collected to assess the clinical utility of the BrainPulse… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- BrainPulse Device
- Type of treatment
- Medical device
- How many people
- 252 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2017to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is expected to enroll up to 289 subjects in total for both parts of the study. During Part I of the study, 40 subjects are expected to be enrolled, of which 20 participants will be assigned to Group A, 5 participants assigned to Group B, 5 participants assigned to Group C, 5 participants assigned to Group D and up to 5 screen failures. In the second part of the study, up to 249 subjects are expected to be enrolled, of which 57 participants will be assigned to Group A1, 57 participants assigned to Group A2, 36 participants assigned to Group D1, and up to 62 participants assigned to group D2, and up to 37 screen failures.
Who may be able to join
- Male or female subjects 18 years or older
- Patient undergoes or will undergo radiological imaging (CT/MR) as part of stroke evaluation (n/a for Group D2)
- Demonstrated at least 1 of the following symptoms (n/a for Group D2):
- Hemiparesis, monoparesis, or quadriparesis
- Hemisensory deficits
- Monocular/binocular visual loss
Show all 20Show fewer
- Visual field deficits
- Diplopia
- Dysarthria
- Facial droop
- Ataxia
- Vertigo
- Aphasia
- Severe and sudden onset of headache
- Nausea, and/or vomiting
- Dizziness
- Altered or loss of consciousness
- Imbalance/ Incoordination
- Last known normal or actual time point, whichever is known, since commencement of symptoms < 48 hours prior to enrollment (n/a for Group D2)
- Consent procedures followed per applicable IRB approvals at site
Who cannot join
- Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/a for Group D2)
- Patient meets the hospital criteria for brain death
- Wound or laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
- Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
- Symptoms due to head trauma
- IV tPA commenced or completed > 4 hours ago
- Any neuro-intervention commenced or completed between admission and time of enrollment
- If does not satisfy the eligibility criteria for groups A, B, C, and D.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwest Community Healthcare
Arlington Heights, Illinois, 60005
University of Cincinnati, Department of Emergency Medicine
Cincinnati, Ohio, 45267-0769
NorthShore University Health System
Evanston, Illinois, 60201
About this study
Official title: Non-Blinded Data Collection Pilot Study of Acute Stroke Using the Brainpulse™
The aim of this pilot study is to collect data on stroke patients and non-stroke patients or healthy volunteers using the BrainPulse Stroke Monitor. Subject characteristics, diagnostic procedures and clinical outcomes will be documented as part of the data collected to assess the clinical utility of the BrainPulse device. All eligible patients and healthy volunteers will be enrolled and assigned to a study Group based on confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across the different study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms and LVO from non-LVO types of strokes. Further assessments will also be made to evaluate if the BrainPulse can identify the presence of stroke.
Read the detailed description
The study is a prospective, non-randomized, non-blinded, hospital-based study of patients presenting with acute stroke symptoms within 48 hours of symptom onset (last known normal or actual time) as evidenced by radiological imaging. The study will be executed in two parts: Study Phase I and Study Phase II. Each study phase will consist of the same sequence of events and study procedures. The first part of the study is designed to enroll a smaller sample size to evaluate the feasibility of incorporating the BrainPulse device in the Stroke patient care workflow.
Patients will be consecutively recruited and once patients have met eligibility, they will be assigned to one of the four study Groups based on their confirmed clinical diagnosis. Each subject will complete one BrainPulse recording before neuro-intervention and within four hours of IV pharmacologic intervention. All subjects will also complete comprehensive neurological, cognitive and NIH Stroke Scale (NIHSS) assessments. Additionally, Ischemic Stroke subjects (Group A) that receive neuro-intervention will complete one additional, and optional BrainPulse recording along with a neurological exam after intervention. If these procedures have been completed as part of standard of care, the data can be captured directly from the medical records. If such procedures were not conducted as part of hospital's standard of care, they will need to be completed for the purpose of the study.
- Conditions
- Stroke, Acute
- Being tested
- BrainPulse Device
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainPulse DeviceDevice
The BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile cerebral blood flow from the cardiac cycle.
The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile cerebral blood flow. The system is powered by a rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Severe Ischemic Stroke | Group A will include subjects that present with focal neurological deficits and clinical features consistent with ischemic stroke. Subjects in this group will have a clinical presentation consistent with ischemic stroke and confirmed by radiological imaging. Subjects in this group need to present with an NIHSS score of greater than or equal to 6. Group A is divided into 2 study sub groups of A1 and A2.
Group A1 are subjects confirmed with acute ischemic stroke secondary to LVO by imaging.
Group A2 are subjects that present with symptoms of acute ischemic stroke and confirmed to not have an LVO ischemic stroke. Receives: Device: BrainPulse Device | |
| Group B: Hemorrhagic Stroke | Subjects in this group will present with symptoms similar to Group A. In addition, they will present with clinical symptoms consistent of increased intracranial pressure such as nausea, vomiting, loss of consciousness and severe headache. In order for a subject to be eligible, the hemorrhage will be limited to primarily intracerebral hemorrhage with a minimum volume of 10mL. Subarachnoid hemorrhage and intraventricular hemorrhage may also be present as incidental findings. Since it is unlikely that these subjects proceed for neuro-intervention, they will not have a follow-up BrainPulse recording and they will be exited after completing study procedures. Receives: Device: BrainPulse Device | |
| Group C: Transient Ischemic Attack | Subjects in this group will present with focal neurological symptoms consistent with stroke. In order for subjects to be eligible for this group, enrollment will need to be within 6 hours of resolution of symptoms along with a confirmation of TIA by treating team. In addition, initial and follow-up radiological imaging needs to show that there are no signs of ischemic stroke or hemorrhage. Receives: Device: BrainPulse Device | |
| Group D: Non-Stroke Subjects | Group D will include control subjects that do not have an acute stroke. They will be sub-divided into Group D1 and D2.
Group D1 subjects will be stroke mimics that present with stroke-like symptoms but do not have a diagnosis of stroke or TIA. In order to qualify for this sub group, subjects will also need to show evidence of no stroke on radiological imaging (CT and/or MRI). Diagnoses in this group may include seizure, systemic infection, brain tumor, metabolic disorder, positional vertigo, hemiplegic migraine, encephalopathy, cranial nerve injury, spinal cord injury, brachial/sacral plexus injury, peripheral nerve injury, etc.
Group D2 subjects will be non-stroke controls that are either patients that present to the hospital for a reason unrelated to stroke and no stroke symptoms or healthy volunteers that are non-clinical visitors or hospital staff. Subjects must have no stroke-like symptoms or suspicion of stroke by the treatment or study team. Receives: Device: BrainPulse Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Stroke subject recordings with non-stroke subject recordings
The primary endpoint in Part I of the study is to enroll and record BrainPulse data from 35 eligible subjects who present with classic stroke symptoms and either have a confirmed diagnosis of stroke or no stroke. The BrainPulse device will be used to analyze and compare the differences in signal characteristics between stroke, TIA and control subjects.
Measured: 6 months
Compare differences in signal charactertistics between LVO stroke and all other subjects
BrainPulse signal of all subjects will be analyzed to compare the difference in signal characteristics between LVO stroke and all other subjects enrolled in the study.
Measured: 12 months
Secondary outcomes (1)
Compare Ischemic stroke subject recordings with hemorrhagic stroke or stroke mimic subject recordings
BrainPulse signal will be analyzed to compare the similarity and difference of the BrainPulse signal between hemorrhagic stroke, ischemic stroke subjects or stroke mimics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start10 Sep 2017
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Walsh, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235271
- Sponsor's protocol ID
- JMC-1701
- Status last verified
- Mar 2025
- First submitted
- 28 Jul 2017
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Blinded Data Collection Pilot Study of Acute Stroke Using the Brainpulse™
- ClinicalTrials.gov ID
- NCT03235271
- Acronym / sponsor ID
- JMC-1701
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot study is to collect data on stroke patients and non-stroke patients or healthy volunteers using the BrainPulse Stroke Monitor. Subject characteristics, diagnostic procedures and clinical outcomes will be documented as part of the data collected to assess the clinical utility of the BrainPulse device. All eligible patients and healthy volunteers will be enrolled and assigned to a study Group based on confirmation of their diagnosis: Acute Ischemic Stroke, Hemorrhagic Stroke, Transient Ischemic Attack or No Stroke. The data collected from the BrainPulse will be compared across the different study groups in an attempt to distinguish stroke from other non-stroke conditions that present with similar symptoms and LVO from non-LVO types of strokes. Further assessments will also be made to evaluate if the BrainPulse can identify the presence of stroke.
Detailed description
The study is a prospective, non-randomized, non-blinded, hospital-based study of patients presenting with acute stroke symptoms within 48 hours of symptom onset (last known normal or actual time) as evidenced by radiological imaging. The study will be executed in two parts: Study Phase I and Study Phase II. Each study phase will consist of the same sequence of events and study procedures. The first part of the study is designed to enroll a smaller sample size to evaluate the feasibility of incorporating the BrainPulse device in the Stroke patient care workflow.
Patients will be consecutively recruited and once patients have met eligibility, they will be assigned to one of the four study Groups based on their confirmed clinical diagnosis. Each subject will complete one BrainPulse recording before neuro-intervention and within four hours of IV pharmacologic intervention. All subjects will also complete comprehensive neurological, cognitive and NIH Stroke Scale (NIHSS) assessments. Additionally, Ischemic Stroke subjects (Group A) that receive neuro-intervention will complete one additional, and optional BrainPulse recording along with a neurological exam after intervention. If these procedures have been completed as part of standard of care, the data can be captured directly from the medical records. If such procedures were not conducted as part of hospital's standard of care, they will need to be completed for the purpose of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Severe Ischemic Stroke | – | Device: BrainPulse DeviceGroup A will include subjects that present with focal neurological deficits and clinical features consistent with ischemic stroke. Subjects in this group will have a clinical presentation consistent with ischemic stroke and confirmed by radiological imaging. Subjects in this group need to present with an NIHSS score of greater than or equal to 6. Group A is divided into 2 study sub groups of A1 and A2. Group A1 are subjects confirmed with acute ischemic stroke secondary to LVO by imaging. Group A2 are subjects that present with symptoms of acute ischemic stroke and confirmed to not have an LVO ischemic stroke. |
| Group B: Hemorrhagic Stroke | – | Device: BrainPulse DeviceSubjects in this group will present with symptoms similar to Group A. In addition, they will present with clinical symptoms consistent of increased intracranial pressure such as nausea, vomiting, loss of consciousness and severe headache. In order for a subject to be eligible, the hemorrhage will be limited to primarily intracerebral hemorrhage with a minimum volume of 10mL. Subarachnoid hemorrhage and intraventricular hemorrhage may also be present as incidental findings. Since it is unlikely that these subjects proceed for neuro-intervention, they will not have a follow-up BrainPulse recording and they will be exited after completing study procedures. |
| Group C: Transient Ischemic Attack | – | Device: BrainPulse DeviceSubjects in this group will present with focal neurological symptoms consistent with stroke. In order for subjects to be eligible for this group, enrollment will need to be within 6 hours of resolution of symptoms along with a confirmation of TIA by treating team. In addition, initial and follow-up radiological imaging needs to show that there are no signs of ischemic stroke or hemorrhage. |
| Group D: Non-Stroke Subjects | – | Device: BrainPulse DeviceGroup D will include control subjects that do not have an acute stroke. They will be sub-divided into Group D1 and D2. Group D1 subjects will be stroke mimics that present with stroke-like symptoms but do not have a diagnosis of stroke or TIA. In order to qualify for this sub group, subjects will also need to show evidence of no stroke on radiological imaging (CT and/or MRI). Diagnoses in this group may include seizure, systemic infection, brain tumor, metabolic disorder, positional vertigo, hemiplegic migraine, encephalopathy, cranial nerve injury, spinal cord injury, brachial/sacral plexus injury, peripheral nerve injury, etc. Group D2 subjects will be non-stroke controls that are either patients that present to the hospital for a reason unrelated to stroke and no stroke symptoms or healthy volunteers that are non-clinical visitors or hospital staff. Subjects must have no stroke-like symptoms or suspicion of stroke by the treatment or study team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is expected to enroll up to 289 subjects in total for both parts of the study. During Part I of the study, 40 subjects are expected to be enrolled, of which 20 participants will be assigned to Group A, 5 participants assigned to Group B, 5 participants assigned to Group C, 5 participants assigned to Group D and up to 5 screen failures. In the second part of the study, up to 249 subjects are expected to be enrolled, of which 57 participants will be assigned to Group A1, 57 participants assigned to Group A2, 36 participants assigned to Group D1, and up to 62 participants assigned to group D2, and up to 37 screen failures.
Key inclusion criteria (20 listed)
- Male or female subjects 18 years or older
- Patient undergoes or will undergo radiological imaging (CT/MR) as part of stroke evaluation (n/a for Group D2)
- Demonstrated at least 1 of the following symptoms (n/a for Group D2):
- Last known normal or actual time point, whichever is known, since commencement of symptoms < 48 hours prior to enrollment (n/a for Group D2)
- Consent procedures followed per applicable IRB approvals at site
Key exclusion criteria (8 listed)
- Not a candidate for radiological imaging (CT/MR) or angiography (CTA/MRA/DSA) (n/a for Group D2)
- Patient meets the hospital criteria for brain death
- Wound or laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
- Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify a patient from participation
- Symptoms due to head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainPulse DeviceThe BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile cerebral blood flow from the cardiac cycle. The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile cerebral blood flow. The system is powered by a rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors. | Device | Group A: Severe Ischemic Stroke, Group B: Hemorrhagic Stroke, Group C: Transient Ischemic Attack, Group D: Non-Stroke Subjects |
Primary outcome
Compare Stroke subject recordings with non-stroke subject recordings
Time frame: 6 months
The primary endpoint in Part I of the study is to enroll and record BrainPulse data from 35 eligible subjects who present with classic stroke symptoms and either have a confirmed diagnosis of stroke or no stroke. The BrainPulse device will be used to analyze and compare the differences in signal characteristics between stroke, TIA and control subjects.
Compare differences in signal charactertistics between LVO stroke and all other subjects
Time frame: 12 months
BrainPulse signal of all subjects will be analyzed to compare the difference in signal characteristics between LVO stroke and all other subjects enrolled in the study.
1 secondary outcome
Compare Ischemic stroke subject recordings with hemorrhagic stroke or stroke mimic subject recordings
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Walsh, MD principal investigator
University of Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Jan Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Stroke subject recordings with non-stroke subject recordings (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.